Activities

Developments in the fields of nanosciences and nanotechnologies in the past few decades have opened up new ways of controlling and manipulating material properties through reduction of particle size down to the nanoscale (1-100 nm). This has led to the development of a number of novel or improved products and applications for a wide range of sectors, including the agricultural and food sector. Nanotechnology is recognized as one of the six Key Enabling Technologies (KETs).

Aside all the projected benefits, the use of nanomaterials has raised concerns that the same nanoscale features that make them desirable for a number of applications may also render them harmful to human health. These concerns originate from the changes in the physicochemical properties of materials that occur when particles are manufactured in the nanoscale, which may also alter their biological fate and behaviour and lead to different or new adverse effects compared to conventional bulk equivalents. In particular, nanoparticles may be able to cross biological membrane barriers that normally prevent larger particulate materials from entering cells and tissues.

Compared to conventional chemical substances, physicochemical characterisation and toxicological testing of nanomaterials is more challenging. Although the current risk assessment paradigm has been broadly considered to be also applicable to nanomaterials, adaptations in certain methods are necessary to take account of the nanoscale particulate nature of nanomaterials.

The European Food Safety Authority (EFSA) has provided two guidance documents on risk assessment in 2021. One outlines the scientific risk assessment and appropriate safety testing of nanomaterials to ensure consumer protection, and the other presents the technical requirements to establish the presence of small particles and how to assess any associated risks in conventional products (i.e. not engineered at the nanoscale).

Risk assessment of nanomaterials is best achieved through integrative approaches. Nanoscale specificities are integrated in the risk assessment process as nanoscale-based hypotheses. New Approach Methodologies (NAMs), avoiding animal testing, are the first choice to generate information for addressing these hypotheses and improve mechanistic understanding of toxicokinetic and toxicodynamic processes at the nanoscale. Integrated Approaches to Testing and Assessment (IATAs) are then used for the integration of human, animal and NAMs-derived evidence. Such framework is oriented towards Next Generation Risk Assessment (NGRA) to harness exposure-led, hypothesis-driven risk assessment approaches. 

The Nanosafety Team of the Department of Food Safety, Nutrition and Veterinary Public Health operates within this context and is active in the following areas:

• Physicochemical characterization of nanomaterials and other particulate materials and their analytical detection in food and in biological specimens.
• Toxicological assessment, with special focus on the use on NAMs for generating evidence, e.g., by in chemico (solubility, dissolution/degradation rate, simulated human GI digestion, lysosomal degradation) and in vitro (advanced models of the intestinal barrier for particle uptake and crossing, cell models addressing tissue and organ toxicity) methods.
• Risk assessment of nanomaterials and other particulate materials either at the national level or in support of the activities carried out by EFSA, i.e. Cross-cutting working group Particle Risk Assessment (assessment of novel foods, food additives, feed additives, food contact materials, pesticides) and EFSA Network for Risk Assessment of Nanotechnologies in Food and Feed; Development of harmonised approaches at the international level within OECD, heading the national delegation in the specific working group (Working Party on Manufactured Nanomaterials, WPMN).

Analytical activities are performed in a unique clean room facility, featuring state-of-the-art equipment and analytical instrumentation such as single particle-ICP-MS and AF4-UV-MALS-DLS-ICP-MS. This structure is the National Reference Laboratory (NRL) for nanomaterials in food and is one of the six European expert laboratories supporting the European Commission Joint Research Centre (Ispra, Italy) in the area of regulatory analytical method development and harmonisation via the Nanomaterials in Food Laboratory Group (NIF-LAG).

In the area of nanotoxicology, the Team established many collaborations with partners in Italy (University of Milan, University of Rome Tor Vergata, IRCCS-Mario Negri) and at the international level (ANSES, RIVM, Vrije Universiteit Brussel), participated in several national and European project and coordinates EFSA-funded European projects in the area on NAMs, such as NANOCELLUP and NAMS4NANO.

The Team is the organizer of the series of the National Conferences ‘Nanotechnologies and nanomaterials in the food sector and their safety assessment’ (2013, 2016, 2019, 2023).